The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Neosporin Scar Solution.
Device ID | K024160 |
510k Number | K024160 |
Device Name: | NEOSPORIN SCAR SOLUTION |
Classification | Elastomer, Silicone, For Scar Management |
Applicant | WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
Contact | John R Jacobs |
Correspondent | John R Jacobs WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
Product Code | MDA |
CFR Regulation Number | 878.4025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-17 |
Decision Date | 2003-03-17 |
Summary: | summary |